Investigation summary: customer returned (1) loose 0.3ml insulin syringe.Consumer reported found 1 syringe without a needle when remove shield.The returned syringe was examined, and it was observed that the needle hub/shield assembly was detached.No damage to the barrel tip was observed.Manufacturing ((b)(4)) will be notified of the observed issue.A review of the device history record was completed for batch #0335581.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa# (b)(4) has been opened to address this issue.
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